NCT06809348 · University of California, San Diego
Development of PRECISE: A Data Driven Personalized Suicide Prevention Intervention
What this study is about
Individuals at high-risk of suicide vary substantially from one another. Over time, risk factors for suicide may change within the same individual. Despite these differences, most treatments for suicidal thoughts assume that the same intervention works equally well for all individuals at high-risk of suicide.
View original scientific description
Individuals at high-risk of suicide vary substantially from one another. Over time, risk factors for suicide may change within the same individual. Despite these differences, most treatments for suicidal thoughts assume that the same intervention works equally well for all individuals at high-risk of suicide. Intensive longitudinal data combined with network science, integrated with coaching, could be used to personalize suicide prevention interventions to make them more effective and efficient. This K23 Career Development application involves refining and testing a novel personalized treatment for individuals at high-risk called PeRsonalizEd Clinical Intervention for Suicidal Events or PRECISE. PRECISE leverages idiographic statistical techniques adopted from network science applied to ecological momentary assessment data to inform the tailoring of Safety Planning and skills from Dialectical Behavior Therapy, two existing evidence-based treatments for suicide. In Aim 1, a user-centered design approach will be used to refine PRECISE. Following the refinement of the intervention, informed by data from a case series in Aim 1, the investigators will then conduct a randomized controlled trial comparing two different intensities of personalization. In the low-intensity arm, the 8-week treatment will be tailored based on an initial two-week burst of ecological momentary assessment and one idiographic model. In the high-intensity arm, participants complete eight weeks of ecological momentary assessment and idiographic models are generated between each session. Coaches use the idiographic models to identify an individuals' drivers of suicidal thoughts and conduct behavioral chain analyses to tailor specific skills to then teach, shape, and reinforce in their individual clients. Assessments are completed pre-treatment, 8-weeks post-enrollment, and 16-weeks enrollment. The investigators hypothesize that both arms will demonstrate clinically significant reductions in suicidal ideation, but the high-intensity arm will be superior to the low-intensity arm in reducing ideation. Furthermore, the investigators anticipate that increases in effective emotion regulation skills and reductions in negative affect will account for the decrease in suicidal ideation. As individuals learn more effective emotion regulation strategies, they will experience less distress and thereby lower levels of suicidal ideation. This project is responsive to Objective 3.2 of the NIMH Strategic Plan and is integrated with a mentored research training plan focused on 1) suicide specific rigorous clinical trials, 2) user centered design in digital health, and 3) applications of network science to intensive longitudinal data. The project and training goal will support the Candidate's overarching goal to become a clinician-scientist engaged in independent research on personalized, impactful, rapid acting suicide prevention interventions for at risk adults.
Interventions
BEHAVIORAL
PRECISE
PRECISE includes aspects of several evidence-based approaches, such as Safety Planning and DBT to manage and reduce suicide risk. During the initial visit, staff train participants how to complete EMAs. Participants then complete two weeks of five-times per day EMAs regarding their emotions, emotion regulation strategies as well as SITBs. Following an initial "learning period", participant data is analyzed via GIMME to determine the within-person correlates of SITBs. Data is processed through a real-time pre-programmed data cleaning and analysis script. Coaches then teach a selection of skills in collaboration with the client.
Primary outcome measures
Scale for Suicide Ideation
Time frame: From enrollment to the end of the follow-up assessment at 6-months.
The Beck Scale for Suicide Ideation (SSI) is a 21-item self-report scale that measure the intensity of suicidal thoughts. The MSSI ranges from 0 \[min\] to 63 \[max\] with higher scores suggesting more severe suicidal ideation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18-65 years old
- Endorsement of active suicidal ideation on the Columbia Suicide Severity Rating Scale (\>2 or past month thoughts of killing self or attempt in past month)
- English fluency
- Willingness to provide contact information for a key information to be contacted as part of our risk and safety plan.
Exclusion criteria
- Past year exposure to DBT
- Moderate/severe substance use disorder within the past thirty days
- Dementia, mild cognitive impairment and/or traumatic brain injury
- Lack of capacity to consent to research and/or under conservatorship.
Where
- San Diego, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 29, 2026 · Source of record for eligibility and locations